# C_2012293EN.01000101.xml

| 28.9.2012 | EN | Official Journal of the European Union | C 293/1 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2012 to 31 August 2012

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
( 1 )
)

2012/C 293/01

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| ---------------------------------------------------------------- | ----------------------------- | ---------------------------------------- | ----------------------------------------------------------------------------------------------- | ----------------------------------------------------- | ---------------------------------------------------------------- | ----------------------------------------------- | ------------------------------------------------ |
| 03.08.2012 | Zoledronic acid medac | zoledronic acid | medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland | medac Gesellschaft für klinische Spezialpräparate mbH | Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/12/779/001-006 | Concentrate for solution for infusion |
| medac Gesellschaft für klinische Spezialpräparate mbH | | | | | | | |
| Theaterstr. 6, D-22880 Wedel, Deutschland | | | | | | | |
| 16.08.2012 | Zoledronic acid Teva | zoledronic acid | TEVA Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | TEVA Pharma B.V. | Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/12/771/001-006 | Concentrate for solution for infusion |
| TEVA Pharma B.V. | | | | | | | |
| Computerweg 10, 3542 DR Utrecht, Nederland | | | | | | | |
| 16.08.2012 | Zoledronic acid Teva Pharma | zoledronic acid | TEVA Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | TEVA Pharma B.V. | Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/12/772/001-004 | Solution for infusion |
| TEVA Pharma B.V. | | | | | | | |
| Computerweg 10, 3542 DR Utrecht, Nederland | | | | | | | |
| 23.08.2012 | Cuprymina | Copper 64Cu chloride | SPARKLE S.r.l. Contrada Calò snc, 73042 Casarano (LE) - Italia | SPARKLE S.r.l. | Contrada Calò snc, 73042 Casarano (LE) - Italia | EU/1/12/784/001 | Radiopharmaceutical precursor, solution |
| SPARKLE S.r.l. | | | | | | | |
| Contrada Calò snc, 73042 Casarano (LE) - Italia | | | | | | | |
| 23.08.2012 | Jakavi | ruxolitinib | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | EU/1/12/773/001-003 | Tablet |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | | | | | | | |
| 23.08.2012 | Zinforo | ceftaroline fosamil | AstraZeneca AB S-151 85 Södertälje, Sverige | AstraZeneca AB | S-151 85 Södertälje, Sverige | EU/1/12/785/001 | powder for concentrate for solution for infusion |
| AstraZeneca AB | | | | | | | |
| S-151 85 Södertälje, Sverige | | | | | | | |
| 23.08.2012 | Zoledronic acid Mylan | zoledronic acid | Mylan S.A.S 117 allée des Parcs,F-69 800 Saint Priest, France | Mylan S.A.S | 117 allée des Parcs,F-69 800 Saint Priest, France | EU/1/12/786/001-003 | Concentrate for solution for infusion |
| Mylan S.A.S | | | | | | | |
| 117 allée des Parcs,F-69 800 Saint Priest, France | | | | | | | |
| 23.08.2012 | Zyclara | imiquimod | Meda AB Pipers väg 2A, 170 73 Solna, Svërige | Meda AB | Pipers väg 2A, 170 73 Solna, Svërige | EU/1/12/783/001-003 | Cream |
| Meda AB | | | | | | | |
| Pipers väg 2A, 170 73 Solna, Svërige | | | | | | | |
| 30.08.2012 | Revestive | teduglutide | Nycomed Danmark ApS Langebjerg 1, DK-4000 Roskilde, Danmark | Nycomed Danmark ApS | Langebjerg 1, DK-4000 Roskilde, Danmark | EU/1/12/787/001 | Powder and solvent for solution for injection |
| Nycomed Danmark ApS | | | | | | | |
| Langebjerg 1, DK-4000 Roskilde, Danmark | | | | | | | |

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --------------------------------------------------------------------------------------------------- | ----------------------------------- | ------------------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
| 03.08.2012 | Hirobriz Breezhaler | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | | | | |
| 03.08.2012 | INCRELEX | Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France | Ipsen Pharma | 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France |
| Ipsen Pharma | | | | |
| 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France | | | | |
| 03.08.2012 | Mabthera | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 03.08.2012 | Olanzapine Mylan | Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | Generics [UK] Limited | Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |
| Generics [UK] Limited | | | | |
| Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | | | | |
| 03.08.2012 | Volibris | Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd | Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Ltd | | | | |
| Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 03.08.2012 | Votrient | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Limited | | | | |
| Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 03.08.2012 | Yondelis | Pharma Mar, S.A. Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), Espana | Pharma Mar, S.A. | Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), Espana |
| Pharma Mar, S.A. | | | | |
| Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), Espana | | | | |
| 08.08.2012 | Kivexa | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| ViiV Healthcare UK Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 08.08.2012 | Olanzapine Teva | Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland | Teva Pharma B.V. | Computerweg 10, DR Utrecht 3542, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, DR Utrecht 3542, Nederland | | | | |
| 22.08.2012 | IDflu | Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France | Sanofi Pasteur SA | 2, avenue Pont Pasteur, F-69007 Lyon, France |
| Sanofi Pasteur SA | | | | |
| 2, avenue Pont Pasteur, F-69007 Lyon, France | | | | |
| 22.08.2012 | Intanza | Sanofi Pasteur MSD SNC 8, rue Jonas Salk, Lyon 69007, France | Sanofi Pasteur MSD SNC | 8, rue Jonas Salk, Lyon 69007, France |
| Sanofi Pasteur MSD SNC | | | | |
| 8, rue Jonas Salk, Lyon 69007, France | | | | |
| 23.08.2012 | Adcirca | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, NL-3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, NL-3991 RA Houten, Nederland | | | | |
| 23.08.2012 | BeneFIX | Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | | | | |
| 23.08.2012 | Brinavess | Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 23.08.2012 | Copalia | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 23.08.2012 | Dafiro | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 23.08.2012 | Docetaxel Teva Pharma | Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland | Teva Pharma B.V. | Computerweg 10, DR Utrecht 3542, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, DR Utrecht 3542, Nederland | | | | |
| 23.08.2012 | Doribax | Janssen-Cilag International NV Turnhoutseweg 30, B - 2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B - 2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B - 2340 Beerse, België | | | | |
| 23.08.2012 | Ecalta | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | |
| 23.08.2012 | Efficib | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 23.08.2012 | Exforge HCT | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 23.08.2012 | Firazyr | Shire Orphan Therapies GmbH Friedrichstrasse 149, D-10117 Berlin, Deutschland | Shire Orphan Therapies GmbH | Friedrichstrasse 149, D-10117 Berlin, Deutschland |
| Shire Orphan Therapies GmbH | | | | |
| Friedrichstrasse 149, D-10117 Berlin, Deutschland | | | | |
| 23.08.2012 | Hepsera | Gilead Sciences International Limited Cambridge, CB21 6GT, United Kingdom | Gilead Sciences International Limited | Cambridge, CB21 6GT, United Kingdom |
| Gilead Sciences International Limited | | | | |
| Cambridge, CB21 6GT, United Kingdom | | | | |
| 23.08.2012 | Humira | Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | Abbott Laboratories Ltd | Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom |
| Abbott Laboratories Ltd | | | | |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | | | | |
| 23.08.2012 | Imprida HCT | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 23.08.2012 | Janumet | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 23.08.2012 | Lysodren | Laboratoire HRA Pharma 15, rue Béranger, 75003 Paris, France | Laboratoire HRA Pharma | 15, rue Béranger, 75003 Paris, France |
| Laboratoire HRA Pharma | | | | |
| 15, rue Béranger, 75003 Paris, France | | | | |
| 23.08.2012 | Macugen | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | | | | |
| 23.08.2012 | Mepact | IDM PHARMA SAS 11-15 quai De Dion Bouton, 92816 Puteaux Cedex, France | IDM PHARMA SAS | 11-15 quai De Dion Bouton, 92816 Puteaux Cedex, France |
| IDM PHARMA SAS | | | | |
| 11-15 quai De Dion Bouton, 92816 Puteaux Cedex, France | | | | |
| 23.08.2012 | Neupro | UCB Manufacturing Ireland Ltd. Shannon Industrial Estate, Co, Clare, Ireland | UCB Manufacturing Ireland Ltd. | Shannon Industrial Estate, Co, Clare, Ireland |
| UCB Manufacturing Ireland Ltd. | | | | |
| Shannon Industrial Estate, Co, Clare, Ireland | | | | |
| 23.08.2012 | Noxafil | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 23.08.2012 | Olazax Disperzi | Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika | Glenmark Pharmaceuticals s.r.o. | City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika |
| Glenmark Pharmaceuticals s.r.o. | | | | |
| City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika | | | | |
| 23.08.2012 | Panretin | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | Eisai Limited | European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom |
| Eisai Limited | | | | |
| European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | | | | |
| 23.08.2012 | Rasilez | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 23.08.2012 | Reyataz | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 23.08.2012 | Riprazo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 23.08.2012 | Thalidomide Celgene | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | Celgene Europe Limited | 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
| Celgene Europe Limited | | | | |
| 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | | | | |
| 23.08.2012 | Vectibix | Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, NL-4817 ZK Breda, Nederland |
| Amgen Europe B.V. | | | | |
| Minervum 7061, NL-4817 ZK Breda, Nederland | | | | |
| 23.08.2012 | Velmetia | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 23.08.2012 | Vfend | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | | | | |
| 23.08.2012 | Vfend | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | | | | |
| 23.08.2012 | Viramune | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | | | | |
| 23.08.2012 | Xgeva | Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, 4817 ZK Breda, Nederland |
| Amgen Europe B.V. | | | | |
| Minervum 7061, 4817 ZK Breda, Nederland | | | | |
| 23.08.2012 | Zavesca | Actelion Registration Ltd BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | Actelion Registration Ltd | BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |
| Actelion Registration Ltd | | | | |
| BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | | | | |
| 23.08.2012 | Zebinix | BIAL - Portela & Ca, SA A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal | BIAL - Portela & Ca, SA | A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal |
| BIAL - Portela & Ca, SA | | | | |
| A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal | | | | |
| 23.08.2012 | Zebinix | BIAL - Portela & Ca, SA A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal | BIAL - Portela & Ca, SA | A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal |
| BIAL - Portela & Ca, SA | | | | |
| A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal | | | | |
| 23.08.2012 | Zostavax | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, F-69007 Lyon, France | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk, F-69007 Lyon, France |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk, F-69007 Lyon, France | | | | |
| 24.08.2012 | FLUENZ | MedImmune, LLC Lagelandseweg 78, 6545 CG Nijmegen, Nederland | MedImmune, LLC | Lagelandseweg 78, 6545 CG Nijmegen, Nederland |
| MedImmune, LLC | | | | |
| Lagelandseweg 78, 6545 CG Nijmegen, Nederland | | | | |
| 27.08.2012 | FLUENZ | MedImmune, LLC Lagelandseweg 78, 6545 CG Nijmegen, Nederland | MedImmune, LLC | Lagelandseweg 78, 6545 CG Nijmegen, Nederland |
| MedImmune, LLC | | | | |
| Lagelandseweg 78, 6545 CG Nijmegen, Nederland | | | | |
| 30.08.2012 | Avastin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 30.08.2012 | Copalia HCT | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 30.08.2012 | Crixivan | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 30.08.2012 | Dafiro HCT | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 30.08.2012 | Enbrel | Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | | | | |
| 30.08.2012 | Evista | DAIICHI SANKYO EUROPE GmbH Zielstattstrasse 48, 81379 München, Deutschland | DAIICHI SANKYO EUROPE GmbH | Zielstattstrasse 48, 81379 München, Deutschland |
| DAIICHI SANKYO EUROPE GmbH | | | | |
| Zielstattstrasse 48, 81379 München, Deutschland | | | | |
| 30.08.2012 | Exforge | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 30.08.2012 | Flebogamma DIF | Instituto Grifols, S.A. Can Guasch, 2 - Parets del Vallès, 08150 Barcelona - Espaňa | Instituto Grifols, S.A. | Can Guasch, 2 - Parets del Vallès, 08150 Barcelona - Espaňa |
| Instituto Grifols, S.A. | | | | |
| Can Guasch, 2 - Parets del Vallès, 08150 Barcelona - Espaňa | | | | |
| 30.08.2012 | Gliolan | medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg - Deutschland | medac Gesellschaft für klinische Spezialpräparate mbH | Fehlandtstrasse 3, D-20354 Hamburg - Deutschland |
| medac Gesellschaft für klinische Spezialpräparate mbH | | | | |
| Fehlandtstrasse 3, D-20354 Hamburg - Deutschland | | | | |
| 30.08.2012 | Imprida | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 30.08.2012 | INCRELEX | Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France | Ipsen Pharma | 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France |
| Ipsen Pharma | | | | |
| 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France | | | | |
| 30.08.2012 | Irbesartan Zentiva | Sanofi 54, rue La Boétie, 75008 Paris, France | Sanofi | 54, rue La Boétie, 75008 Paris, France |
| Sanofi | | | | |
| 54, rue La Boétie, 75008 Paris, France | | | | |
| 30.08.2012 | Januvia | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 30.08.2012 | Kaletra | Abbott Laboratories Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom | Abbott Laboratories | Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom |
| Abbott Laboratories | | | | |
| Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom | | | | |
| 30.08.2012 | Leganto | UCB Manufacturing Ireland Ltd. Shannon Industrial Estate, Co, Clare, Ireland | UCB Manufacturing Ireland Ltd. | Shannon Industrial Estate, Co, Clare, Ireland |
| UCB Manufacturing Ireland Ltd. | | | | |
| Shannon Industrial Estate, Co, Clare, Ireland | | | | |
| 30.08.2012 | Methylthioninium chloride Proveblue | Provepharm S.A.S. Technopole de Chateau Gombert, 45 rue Frederic Joliot Curie, FR-13013 Marseille | Provepharm S.A.S. | Technopole de Chateau Gombert, 45 rue Frederic Joliot Curie, FR-13013 Marseille |
| Provepharm S.A.S. | | | | |
| Technopole de Chateau Gombert, 45 rue Frederic Joliot Curie, FR-13013 Marseille | | | | |
| 30.08.2012 | Modigraf | Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland | Astellas Pharma Europe B.V. | Elisabethhof 19, 2353 EW Leiderdorp, Nederland |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19, 2353 EW Leiderdorp, Nederland | | | | |
| 30.08.2012 | Multaq | Sanofi 54, rue La Boétie, 75008 Paris, France | Sanofi | 54, rue La Boétie, 75008 Paris, France |
| Sanofi | | | | |
| 54, rue La Boétie, 75008 Paris, France | | | | |
| 30.08.2012 | Olanzapine Glenmark Europe | Glenmark Generics (Europe) Limited Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom | Glenmark Generics (Europe) Limited | Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom |
| Glenmark Generics (Europe) Limited | | | | |
| Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom | | | | |
| 30.08.2012 | Optruma | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, 3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, 3991 RA Houten, Nederland | | | | |
| 30.08.2012 | Pradaxa | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 30.08.2012 | Pravafenix | LABORATOIRES SMB SA 26-28 rue de la Pastorale, 1080 Bruxelles, Belgique / 26-28 Herdersliedstraat, 1080 Brussel, België | LABORATOIRES SMB SA | 26-28 rue de la Pastorale, 1080 Bruxelles, Belgique / 26-28 Herdersliedstraat, 1080 Brussel, België |
| LABORATOIRES SMB SA | | | | |
| 26-28 rue de la Pastorale, 1080 Bruxelles, Belgique / 26-28 Herdersliedstraat, 1080 Brussel, België | | | | |
| 30.08.2012 | Protopic | Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland | Astellas Pharma Europe B.V. | Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland | | | | |
| 30.08.2012 | ReFacto AF | Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | | | | |
| 30.08.2012 | Ristaben | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 30.08.2012 | Ristfor | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 30.08.2012 | Sprycel | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 30.08.2012 | Telmisartan Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, 3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, 3542 DR Utrecht, Nederland | | | | |
| 30.08.2012 | Tygacil | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom | | | | |
| 30.08.2012 | Vedrop | Orphan Europe SARL Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92 800 Puteaux - France | Orphan Europe SARL | Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92 800 Puteaux - France |
| Orphan Europe SARL | | | | |
| Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92 800 Puteaux - France | | | | |
| 30.08.2012 | Votrient | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Limited | | | | |
| Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 30.08.2012 | Zytiga | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| ---------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------------------------------- |
| 08.08.2012 | MabCampath | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, NL-1411 DD Naarden, Nederland |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10, NL-1411 DD Naarden, Nederland | | | | |
| 23.08.2012 | Zerene | Meda AB Pipers väg 2A, Solna 170 09, Sverige | Meda AB | Pipers väg 2A, Solna 170 09, Sverige |
| Meda AB | | | | |
| Pipers väg 2A, Solna 170 09, Sverige | | | | |
| 30.08.2012 | Riprazo HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | | | | |

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| ------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------ | ---------------------------------------------- | ------------------------------------------------------- |
| 16.08.2012 | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, IRELAND | Chanelle Pharmaceuticals Manufacturing Limited | Loughrea, Co. Galway, IRELAND |
| Chanelle Pharmaceuticals Manufacturing Limited | | | | |
| Loughrea, Co. Galway, IRELAND | | | | |
| 30.08.2012 | Dexdomitor | Orion Corporation Orionintie 1, FIN-02200 Espoo, Suomi | Orion Corporation | Orionintie 1, FIN-02200 Espoo, Suomi |
| Orion Corporation | | | | |
| Orionintie 1, FIN-02200 Espoo, Suomi | | | | |
| 30.08.2012 | Nobivac Bb | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | | | | |
| 30.08.2012 | Suvaxyn Aujeszky 783 +O/W | Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | | | | |

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| ----------------------------- |
| 7, Westferry Circus, |
| Canary Wharf |
| UK - LONDON E14 4H |

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( 1 )  OJ L 136, 30.4.2004, p. 1.

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